scholarly journals Efficacy of a mindfulness-based intervention programme with and without virtual reality support to reduce stress in university students: protocol for a randomized controlled pragmatic trial

2021 ◽  
Author(s):  
Marta Modrego-Alarcón ◽  
María Teresa Navarro-Gil ◽  
María Beltrán-Ruiz ◽  
Alicia Monreal-Bartolomé ◽  
Santiago Gascón ◽  
...  
Keyword(s):  
Virtual Reality ◽  
University Students ◽  
Perceived Stress ◽  
Well Being ◽  
Self Report ◽  
Control Group ◽  
Large Sample Size ◽  
Randomized Controlled ◽  
The Impact

Abstract Background: There is growing concern about mental health problems in university students. For this reason, mindfulness training is becoming increasingly popular in university settings. However, mindfulness-based interventions (MBIs) usually present high attrition rates. This trial aims to evaluate the efficacy of a MBI to reduce perceived stress and to improve the psychological well-being of university students, as well as to explore the capacity of virtual reality (VR) to enhance adherence to the intervention. Methods: This study protocol presents a randomized controlled trial (RCT) involving assessment time points of baseline, posttreatment and 6-month follow-up. A total of 280 students from the Spanish National Distance Education University (UNED) or the University of Zaragoza will be randomly assigned to a mindfulness condition, a mindfulness condition complemented by VR, and a relaxation condition to serve as a control group. Stress will be the main outcome and will be measured using the 10-item self-report Perceived Stress Scale (PSS). Other well-being and academic functioning outcomes will be assessed, as well as variables that explore the impact of VR. Multilevel mixed-effects models will be calculated to estimate the efficacy of the programme, and effect size estimations will be carried out. Effects of VR in adherence to programme will be evaluated. Discussion: Some strengths of this study are the RCT design, which includes a suitable active control group and a 6-month follow-up assessment; a large sample size of university students at different stages of their courses and a variety of degrees; and the incorporation of the VR support to facilitate completion of the MBI programme. Potential limitations are the voluntary participation of the students and the utilization of self-report measures.Trial registration number: ClinicalTrials.gov NCT03771300.

scholarly journals Efficacy of a mindfulness-based intervention programme with and without virtual reality support to reduce stress in university students: protocol for a randomized controlled pragmatic trial

2019 ◽  
Author(s):  
Marta Modrego-Alarcón ◽  
María Teresa Navarro-Gil ◽  
María Beltrán-Ruiz ◽  
Alicia Monreal-Bartolomé ◽  
Santiago Gascón ◽  
...  
Keyword(s):  
Virtual Reality ◽  
University Students ◽  
Perceived Stress ◽  
Well Being ◽  
Self Report ◽  
Control Group ◽  
Large Sample Size ◽  
Randomized Controlled ◽  
The Impact

Abstract Background There is growing concern about mental health problems in university students. For this reason, mindfulness training is becoming increasingly popular in university settings. However, mindfulness-based interventions (MBIs) usually present high attrition rates. This trial aims to evaluate the efficacy of a MBI to reduce perceived stress and to improve the psychological well-being of university students, as well as to explore the capacity of virtual reality (VR) to enhance adherence to the intervention. Methods This study protocol presents a randomized controlled trial (RCT) involving assessment time points of baseline, posttreatment and 6-month follow-up. A total of 280 students from the Spanish National Distance Education University (UNED) or the University of Zaragoza will be randomly assigned to a mindfulness condition, a mindfulness condition complemented by VR, and a relaxation condition to serve as a control group. Stress will be the main outcome and will be measured using the 10-item self-report Perceived Stress Scale (PSS). Other well-being and academic functioning outcomes will be assessed, as well as variables that explore the impact of VR. Multilevel mixed-effects models will be calculated to estimate the efficacy of the programme, and effect size estimations will be carried out. Effects of VR in adherence to programme will be evaluated. Discussion Some strengths of this study are the RCT design, which includes a suitable active control group and a 6-month follow-up assessment; a large sample size of university students at different stages of their courses and a variety of degrees; and the incorporation of the VR support to facilitate completion of the MBI programme. Potential limitations are the voluntary participation of the students and the utilization of self-report measures. Trial registration number ClinicalTrials.gov NCT03771300.

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Silvina Catuara-Solarz ◽  
Bartlomiej Skorulski ◽  
Inaki Estella ◽  
Claudia Avella-Garcia ◽  
Sarah Shepherd ◽  
...  
Keyword(s):  
Mental Health ◽  
Perceived Stress ◽  
Intervention Group ◽  
Well Being ◽  
Self Report ◽  
World Health ◽  
Randomised Control Trial ◽  
Control Group ◽  
Mental Well Being ◽  
Proof Of Principle

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

scholarly journals Effects of individualized follow-up with a smartphone-application after cardiac rehabilitation: protocol of a randomized controlled trial

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Pernille Lunde ◽  
Asta Bye ◽  
Astrid Bergland ◽  
Birgitta Blakstad Nilsson
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Rehabilitation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Smartphone Application ◽  
Control Group ◽  
Power Calculation ◽  
Large Sample Size ◽  
Randomized Controlled

Abstract Background Cardiac rehabilitation (CR) programs are evidence-based and widely recommended. However, benefits from CR are likely lost among individuals who discontinue their regular exercise routines and healthy habits. One possible approach to enhance adherence to lifestyle advice after completion of CR, may be individualized follow-up enabled by a smartphone application (app). Methods A protocol of a single-blinded, pragmatic randomized controlled trial. The study will take place in the eastern part of Norway, and will include heart patients who have completed CR. Participants will be recruited from two CR centers. Based on power calculation, 113 participants will be included. The intervention group will receive individualized follow-up through an app on a weekly basis throughout a year. The app will be set up with the participant’s own goals, and the follow-up will be based on these individual goals. The control group will receive usual care, including general advice regarding physical activity, exercise and diet. The participants will be assessed at baseline (at completion of CR) and 12 months after baseline. Primary outcome of the study will be peak oxygen uptake. Secondary outcomes include exercise performance, quality of life, health status, health literacy, self-perceived goal achievement, exercise habits, body weight, blood pressure as well as lipids and triglycerides. Discussion To our knowledge, this will be the first study to examine the effects of individualized follow-up with an app for one year, in patients completing CR. Hence, it is reasonable to assume that the study may be groundbreaking. Due to the large sample size and the theoretically based intervention, the study has the potential to generate new knowledge that may improve the design of future technology-based follow-up interventions of patients that have completed rehabilitation. Trial registration ClinicalTrials.gov. NCT03174106. First registration, 19/05/2017.

Effect of Meditation on Social/Emotional Well-Being in a High-Performing High School

2019 ◽  
Vol 23 (1) ◽  
pp. 2156759X2094063
Author(s):  
Jane E. Bleasdale ◽  
Margaret C. Peterson ◽  
Sanford Nidich
Keyword(s):  
High School ◽  
School Counselors ◽  
Perceived Stress ◽  
Well Being ◽  
Self Esteem ◽  
Anxiety And Depression ◽  
Social Emotional ◽  
High Performing ◽  
Randomized Controlled ◽  
The Impact

This study explored the impact of a meditation program on stress, anxiety, and depression in a high-performing high school. Using a randomized controlled design with 52 students, the study took place over 4 months. Students participated in Transcendental Meditation (treatment) or silent reading (active control) twice daily. We observed significant reductions in perceived stress ( p = .040), anxiety ( p = .028), anger ( p = .047), depression ( p = .024), and fatigue ( p = .075), and improvement in self-esteem ( p = .054). The program has important implications for school counselors because of the impact on social/emotional well-being.

scholarly journals Evaluation of a Seven-Week Web-Based Happiness Training to Improve Psychological Well-Being, Reduce Stress, and Enhance Mindfulness and Flourishing: A Randomized Controlled Occupational Health Study

2013 ◽  
Vol 2013 ◽  
pp. 1-14 ◽  
Author(s):  
T. Feicht ◽  
M. Wittmann ◽  
G. Jose ◽  
A. Mock ◽  
E. von Hirschhausen ◽  
...  
Keyword(s):  
Occupational Health ◽  
Controlled Trial ◽  
Well Being ◽  
Self Report ◽  
Health Study ◽  
Psychological Well Being ◽  
Web Based ◽  
Attention Network ◽  
Randomized Controlled ◽  
The Impact

Background. As distress in society increases, including work environments, individual capacities to compete with stress have to be strengthened.Objective. We examined the impact of a web-based happiness training on psychological and physiological parameters, by self-report and objective means, in an occupational health setting.Methods. Randomized controlled trial with 147 employees. Participants were divided into intervention (happiness training) and control groups (waiting list). The intervention consisted of a seven-week online training. Questionnaires were administered before, after, and four weeks after training. The following scales were included: VAS (happiness and satisfaction), WHO-5 Well-being Index, Stress Warning Signals, Freiburg Mindfulness Inventory, Recovery Experience Questionnaire, and Flourishing Scale. Subgroup samples for saliva cortisol and alpha-amylase determinations were taken, indicating stress, and Attention Network Testing for effects on attention regulation.Results. Happiness (P=0.000;d=0.93), satisfaction (P=0.000;d=1.17), and quality of life (P=0.000;d=1.06) improved; perceived stress was reduced (P=0.003;d=0.64); mindfulness (P=0.006;d=0.62), flourishing (P=0.002;d=0.63), and recovery experience (P=0.030;d=0.42) also increased significantly. No significant differences in the Attention Network Tests and saliva results occurred (intergroup), except for one saliva value.Conclusions. The web-based training can be a useful tool for stabilizing health/psychological well-being and work/life balance.

PHARMACEUTICAL CARE OF ADOLESCENTS WITH DIABETES MELLITUS TYPE 1: THE DIADEMA STUDY, A RANDOMIZED CONTROLLED TRIAL

2015 ◽  
Vol 101 (1) ◽  
pp. e1.67-e1
Author(s):  
Emina Obarčanin ◽  
Manfred Krueger ◽  
Petra Mueller ◽  
Verena Nemitz ◽  
Holger Schwender ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Pharmaceutical Care ◽  
Intervention Group ◽  
Well Being ◽  
Diabetes Mellitus Type ◽  
Control Group ◽  
Randomized Controlled ◽  
Phone Calls ◽  
The Impact

BackgroundAdolescents with type 1 diabetes mellitus (T1DM) often show low adherence to complex insulin regimens, leading to poor glycemic control. The benefit of pharmaceutical care in adults with diabetes mellitus type 2 (T2DM) has been widely explored; however, evidence in adolescents with T1DM remains scarce.ObjectiveTo evaluate the impact of pharmaceutical care in adolescents with T1DM provided by a multidisciplinary team on multiple important clinical outcomes.SettingAt the outpatient Helios Paediatric Clinic and at the 12 regular community pharmacies of the study patients with 14 pharmacists in the Krefeld area, Germany, and at the University Pediatric Clinic with one pharmacist on-site in Sarajevo, Bosnia-Herzegovina.MethodsA randomized, controlled, prospective, multicenter study in 68 adolescents with T1DM. The intervention group received monthly structured pharmaceutical care delivered by pharmacists plus supplementary phone calls for 6 months. The control group received usual diabetic care. Data were collected at baseline and after 3 and 6 months. In addition, HbA1c was measured after 12 months.Main outcome measures The between-group difference in the change from baseline in glycosylated hemoglobin (HbA1c), the number of severe hypoglycemic events in both groups, and patient well-being in the intervention group.ResultsThe improvement from baseline in HbA1c was significantly greater in the intervention group than in the control group after 6 months (change from baseline −0.54 vs. +0.32%, p=0.0075), even after adjustment for country-specific variables (p=0.0078). However, the effect was more pronounced after only 3 months (−1.09 vs. +0.23%, p=0.00002). There was no significant between-group difference in the number of severe hypoglycemia events. After 6 months, the well-being according to the WHO-5 index in the intervention group increased significantly from 52.8% to 63.3%. After 12 months the mean total HbA1c remained significantly reduced in the intervention compared to the control group (8.6% vs. 9.5%, p=0.0184).ConclusionThe improved outcomes seen in this study provide new evidence that pharmaceutical care adds value to the management of T1DM in adolescents. However, the optimal methods of achieving sustained long-term improvements in this specific patient population require further study.

scholarly journals Outcomes of Visual Self-Expression in Virtual Reality on Psychosocial Well-Being With the Inclusion of a Fragrance Stimulus: A Pilot Mixed-Methods Study

2020 ◽  
Vol 11 ◽  
Author(s):  
Girija Kaimal ◽  
Katrina Carroll-Haskins ◽  
Arun Ramakrishnan ◽  
Susan Magsamen ◽  
Asli Arslanbek ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Mixed Methods ◽  
Negative Affect ◽  
Self Efficacy ◽  
Well Being ◽  
Mixed Methods Study ◽  
Self Report ◽  
Art Making ◽  
Creative Agency ◽  
The Impact

AimsIn this pilot mixed-methods study, we examined the participants experiences of engaging in virtual drawing tasks and the impact of an olfactory stimulus (calming fragrance blend) on outcomes of affect, stress, self-efficacy, anxiety, creative agency, and well-being (satisfaction with life).MethodsThis study used a parallel mixed-methods, simple block randomization design. The study participants included 24 healthy adults aged 18 to 54 years, including 18 women and six men. The participants completed two 1-h immersive virtual art making sessions and were randomly assigned to receive either a fragrance or a non-fragrance condition for the first session. Quantitative (standardized self-report measures) and qualitative (open-ended survey responses and virtual artwork) datasets were collected concurrently and integrated during data analysis.ResultsThe quantitative results indicated that the fragrance condition demonstrated a significant reduction in negative affect (e.g., feeling hostile, jittery, upset, distressed, etc.), namely, reduced feelings of negativity when compared to the non-fragrance condition. A trend toward improvement in self-efficacy was also seen in the fragrance condition. No significant changes were found for fragrance or non-fragrance conditions for positive affect, anxiety, and creative agency. The qualitative findings included five themes related to art making experiences in virtual reality in both conditions: fun and joy; novelty of virtual media, experimentation, and play; relaxation and calm; learning curve; and physical discomfort and disorientation. Four themes were identified for virtual art content and visual qualities: nature imagery, references to memories and personal symbols, fantasy and play within imagery, and depiction of everyday objects.ConclusionsOverall, the participants reported positive responses to the novel virtual art making experiences which were further heightened by the inclusion of the fragrance stimulus for negative affect. These preliminary findings need to be replicated with larger sample sizes to confirm the outcomes and the trends that were seen in this pilot study. Further research is recommended to examine the differences between experiences of virtual and traditional art media and to examine different olfactory stimuli promoting focus and concentration.

The effectiveness of a non-guided mindfulness application on perceived stress in a non-clinical Dutch population: a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Leonieke W Kranenburg ◽  
Jamie Gillis ◽  
Birgit Mayer ◽  
Witte JG Hoogendijk
Keyword(s):  
Randomized Controlled Trial ◽  
Perceived Stress ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Dutch Population ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) to reduce stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth. OBJECTIVE The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months. METHODS A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model. RESULTS At baseline, 587 respondents were included. Results showed no differences between groups for the level of perceived stress. With regard to the secondary outcome measures, the VAS for emotional exhaustion and physical exhaustion showed statistically significant lower scores for the experimental group after 8 weeks (resp. p=.04 and p= .01), but not at follow-up. There were also no differences between groups found for psychological symptoms. CONCLUSIONS These findings do not support our hypothesis that using the mindfulness app would reduce stress levels. However, findings with regard to diminished exhaustion at 8 weeks are encouraging and require further investigation.

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